Manufacturing, Biologic Drugs

Scinai Bioservices Inc. has been established in Delaware as the company's new US-based subsidiary, which will serve biotech companies in early stage drug development.

FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.

Sanofi will use this investment to increase its antibody bioproduction at its site in Lyon Gerland, France.

SEKISUI has used a £15.7 million (US$20.7 million) investment to expand its clinical-grade drug substance manufacturing at its UK site.

Financing from OrbiMed, Novo Holdings, Jeito Capital, and others will enable Alentis Therapeutics to advance its pipeline of Claudin-1-targeted ADCs for treating solid tumors.

Executives at Avantor talk about the future of the biopharmaceutical industry and the anticipated impact that a wave of next-generation biotherapeutics will bring.

Under an ongoing partnership with Merck, known as MSD outside of the United States and Canada, Ginkgo Bioworks has achieved the first milestone in a project aimed at improving biologics production.

Synaffix, a Lonza company, has licensed its ADC technology to BigHat Biosciences to be combined with the latter's ML design platform to develop new ADCs

The Mobius ADC Reactor is the first single-use reactor designed specifically for the manufacture of antibody drug conjugates.

Lilly has added a $1 billion investment to increase biologics manufacturing at its Limerick, Ireland, site while unveiling its new $800 million facility in Kinsale.

Scorpius Holdings is set to launch its first CGMP manufacturing campaign at its San Antonio, Texas, facility for mammalian cell culture in the 2024 third quarter.

BeiGene has opened its new $800 million Hopewell, NJ-based biologics manufacturing facility, which also houses the company's clinical R&D capabilities.

HCPs are major process-related impurities that must be monitored throughout biologics production for clearance.

Ecolab Life Sciences and Repligen have launched a new affinity resin, DurA Cycle, for large-scale biologics manufacturing.

Syngene's new production platform offers rapid protein synthesis with lower risk.

The completed expansion at AGC Biologics'Copenhagen, Denmark, site, doubles the company's single-use bioreactor capacity for mammalian-based services.

The biopharma industry is looking at continuous chromatography for sensitive molecules.

Pharm Tech Group chats with Dr. Monika Paulė, CEO and co-founder of Caszyme about the evolution of CRISPR.

A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.

The partnership aims to provide end-to-end development and manufacturing for biopharmaceutical drug substance and drug product.

The new facility will be the company’s first to offer full manufacturing processing for antibody drug conjugates.

A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.

The improvement of ADC manufacturing now demands increased containment requirements and continually advancing analytical detection of molecules in manufacturing spaces.

WMFTS has launched WMArchitect, a single-use product line that offers ready-to-use single-use assemblies and custom-designed workflows for biopharma fluid management.

Under a collaboration agreement, Lonza will manufacture sabirnetug, Acumen Pharmaceuticals' mAb in clinical development for treating Alzheimer’s disease.

The Vacaville, Calif., site acquisition gives Lonza one of the largest biologics manufacturing sites for mammalian cell-based therapies worldwide.

Mapp Biopharmaceutical will use ProBioGen’s GlymaxX technology for the development of an afucosylated antibody against Marburg virus infection

The evolution of therapeutic modalities drives the adoption of single-use technologies.

In a new manufacturing pact, Chime Biologics will produce DT-7012, Domain Therapeutics' antibody candidate for treating cancer that will soon be entering Phase I studies.

Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.